Once-Daily Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Sex.
J Drugs Dermatol
; 19(8): 777-783, 2020 08 01.
Article
em En
| MEDLINE
| ID: mdl-32845584
ABSTRACT
Background:
Two identical phase 3 randomized, double-blind, vehicle-controlled, 12-week studies (NCT03168321 and NCT03168334) demonstrated the efficacy and safety of tazarotene 0.045% lotion in participants with moderate-to-severe acne. Data from these studies were pooled and analyzed post hoc to evaluate outcomes by sex.Methods:
Patients aged ≥9 years with moderate-to-severe acne (score 3 or 4 on the Evaluator's Global Severity Score [EGSS]) were randomized (11) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Outcomes comprised inflammatory/noninflammatory lesion counts, treatment success (proportion of participants achieving ≥2-grade reduction from baseline in EGSS and score of 0 ["clear"] or 1 ["almost clear"]), and treatment-emergent adverse events (TEAEs).Results:
A total of 1,064 females and 550 males were included in this analysis. For both sexes, least-squares mean percent changes from baseline to week 12 in lesion counts were significantly greater with tazarotene 0.045% lotion versus vehicle (inflammatory females, -60.1% vs -52.1%; males, -53.6% vs -39.8%; noninflammatory females, -57.6% vs -44.9%; males, -52.9% vs -36.5%; P<0.001, all). The percentage of participants achieving treatment success at week 12 was also significantly higher with tazarotene 0.045% lotion versus vehicle in females and males (P<0.001, both). Compared with tazarotene-treated males, tazarotene-treated females had significantly greater changes from baseline in inflammatory and noninflammatory lesions and a greater proportion achieved treatment success at week 12 (P<0.05, all). TEAE rates were similar between tazarotene- and vehicle-treated males; rates were higher for tazarotene-treated females than vehicle-treated females.Conclusions:
Tazarotene 0.045% lotion was efficacious and well tolerated in the treatment of moderate-to-severe acne in female and male participants. J Drugs Dermatol. 2020;19(8) doi10.36849/JDD.2020.5249
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Acne Vulgar
/
Creme para a Pele
/
Ceratolíticos
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Ácidos Nicotínicos
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Limite:
Adolescent
/
Adult
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Child
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Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article